Combined Intramedullary - Extramedullary Bone Stabilization and Alignment System

ABSTRACT

Disclosed is a combined intramedullary and extramedullary bone stabilization and alignment system, which includes both methods and apparatuses for the alignment and stabilization of a first bone or piece of bone to a second bone or piece of bone. Embodiments of the system may include an implant device which has an elongated framework within the intramedullary portion and an extramedullary portion which are cannulated. The cannulated aspect of the framework includes a wire aperture through both the intramedullary portion and the extramedullary portion.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. patent application Ser. No.15/418,130, filed Jan. 27, 2017, which claims the benefit of U.S. patentapplication Ser. No. 14/733,451, filed Jun. 8, 2015, which has maturedinto U.S. Pat. No. 10,226,292.

TECHNICAL FIELD

This invention pertains to a combined intramedullary and extramedullarystabilization and alignment system for use on the bones and joints ofmammals.

BACKGROUND OF THE INVENTION

For many years numerous surgical procedures have been performed tostabilize and align (or re-align) parts of the skeletal structure ofmammals. These surgeries include the alignment of existing joints aswell as the fusion or attachment of one part of a bone to another partof a bone that have been separated surgically or otherwise. A surgicalosteotomy for example is a procedure where a bone is cut to change thealignment (lengthen, shorten or otherwise change).

Bunion and/or hallux valgus surgeries are examples of applications forsome embodiments of this invention wherein a bone is surgically cut orseparated into two pieces or portions (osteotomy), and then surgicallyfixed back together in a more desired multi-planar and/or rotationalalignment and stabilization. “Hallux” is used as another name for aperson's big toe, and generally includes two bones or “phalanges” andvalgus generally refers to a deformation of a bone or joint. The term“hallux valgus” typically refers to a deviation of the big or great toetoward the inside portion or fibular border of the foot.

An example of this type of surgical procedure relates to bunion surgery,which may also be referred to as a bunionectomy or a surgical procedureto correct or relieve a bunion. A bunion is a distortion or enlargementof a joint in the big toe which causes the big toe to curve outwardlytoward the other toes in the foot. The metatarsal bone protrudesmedially and can rotate externally (see FIG. 1).

In a typical foot the first intermetatarsal angle is in the five to tendegree range (generally under fifteen degrees), whereas in a foot withmetatarsus primus varus, the first intermetatarsal angle may be greaterthan fifteen degrees and can increase to twenty degrees or more. The“first” intermetatarsal angle is the angle between the first and secondmetatarsal bones. A metatarsus primus varus is a condition in which thefirst metatarsal bone has an increased angle away from the secondmetatarsal bone and some rotational distortion.

Some estimate there are approximately two-hundred thousand tofour-hundred thousand bunion or Hallux Valgus (HV) surgical proceduresperformed every year. Metatarsus primus generally occurs along withbunion and hallux valgus.

The difficulties with some of the prior art surgical procedures aremultiple and many modifications of the basic procedure have beenproposed and explored. However, despite the years of attempts to modifythe bunionectomy, there is still a relatively high rate of patientdissatisfaction with bunion and hallux valgus types of surgeries.

In the bunion surgery example the deformity most often addressed by thesurgical procedure is the increase in the angle between the first andsecond metatarsals, an example of which is illustrated in FIG. 1 (angle93). The view of the deformity shown in FIG. 1 only shows one plane ofdeformation whereas in most bunion conditions the patient has deformityin multiple planes and some further include rotational deformity (angle94, FIG. 1). In the prior art these deformity angles may be referred toas the first intermetatarsal angle (“IMA”) and the secondintermetatarsal angle, with the first intermetatarsal angle being theangle between the first and the second metatarsal bones.

It is believed that in many bunion surgeries the failure to recognizeand/or solve the frontal plan rotation deformation for example, resultsin less than desirable surgical results. The prospects for a successfulsurgical procedure are further limited by the difficulties associatedwith the imprecise nature of being able to more precisely view and alignthe two part/portions of the bones or portions/parts/pieces of bonesbeing fixed together (or the joint being re-aligned).

Only a few of the existing surgical procedures or systems address boththe translational and rotational deformity issues. One of the mostcommon surgical procedures used to address the translational androtational deformity issues is referred to as a Lapidus Bunionectomy, inwhich the first metatarsal is fixed to the medial cunefiform.Unfortunately the Lapidus Bunionectomy has historically had a four tosix week non-weight bearing postoperative healing period.

Despite the longstanding and recognized need for an improved system toaddress the various deformities and/or issues typically associated withskeletal or bone misalignment and/or deformity in mammals, there isstill a need for an improved system.

Aspects of this invention such as the cannulated aspect of the implantdevice have an advantage of providing the surgeon an additionalalignment tool for use during the surgery in combination with what isreferred to as a wire or “K-wire”. The term K-wire is used broadly inthe surgical field to refer to a wire or pin that may have numerousdeviations (sharpened portions, threaded portions, various or varyingthicknesses, etc). K-wires were originally referred to as Kirschnerwires because Martin Kirschner was originally credited with theintroduction of the wires into surgery in the early 1900's.

In surgeries, K-wires may be conveniently used for temporary orpermanent fixation. In some applications K-wires may first be insertedinto one part or portion of the bone or joint, and then theintramedullary and extramedullary portions of one embodiment of theinvention can be slid over the K-wire to achieve more consistentimproved alignment of the device. This will lead to more consistentdesired (or improved) alignment of the joint and/or fusion.

There are substantial opportunities in these types of surgeries forimprovement in the precise placement and fixation of the metatarsalhead, to meet two objectives of the surgery, namely the centering of themetatarsal head over the sesamoid, and the angular alignment orrotational adjustment to reduce the angle between the first and secondmetatarsals.

Generally, after the implant device is attached to the metatarsal headit is oftentimes desirable, but not very feasible under currenttechnology, to make micro-adjustments to manipulate or move themetatarsal head laterally or rotationally/angularly. Embodiments andaspects of this invention provide the surgeon with the ability to makethese lateral and rotational micro-adjustments to, for example, centerthe metatarsal head over the sesamoid or the sesamoid apparatus and tomake the desired rotational or angular adjustment. At this stage of thesurgery an axial view of the sesamoid may provide the surgeon the imageto allow the surgeon to accurately see how much rotation or angularadjustment may be needed in order to micro adjust the metatarsal headinto as near to the exact position as can be accomplished. The currenttechnology heretofore has not provided a sufficient ability (or anyability) to make such micro-adjustments, including using the sesamoid ataxial view.

Aspects of this embodiment provide a new and novel ability to makepost-attachment adjustments to position the metatarsal head, byproviding a system which allows the surgeon to make post plateattachment adjustments to position the metatarsal head laterally androtationally/angularly.

It is therefore an object of aspects or embodiments of this invention toprovide a system and tool whereby post attachment adjustments (includingmicro adjustments) can be made to finally position or fixate themetatarsal head laterally and rotationally/angularly more accurately.

It is a further object of some embodiments of this invention to providean adjustment tool, integral with or separate from the drill and/or wireguide or template, is attachable and detachable to and from the implantdevice, to provide for the post metatarsal head attachment adjustment ofthe position (such as lateral position) and the angular position of themetatarsal head.

It is therefore an object of some embodiments of this invention toprovide an improved stabilization and/or alignment system which may beused to address bone and joint alignment issues generally, and which mayinclude foot related bunion and unwanted metatarsal deformations.

It is a further object of this invention to provide such system whichprovides an improved alignment tool during the surgical procedure, suchas by providing a cannulated intramedullary portion that is disposed tobe inserted into a bone over the wire or k-wire as a guide. It is afurther object to provide such a system wherein the extramedullaryportion is also cannulated.

Other objects, features, and advantages of this invention will appearfrom the specification, claims, and accompanying drawings which form apart hereof. In carrying out the objects of this invention, it is to beunderstood that its essential features are susceptible to change indesign and structural arrangement, with only one practical and preferredembodiment being illustrated in the accompanying drawings, as required.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention are described below withreference to the following accompanying drawings.

FIG. 1 is a top view of bones in a typical human foot illustratingbunion and metatarsal issues;

FIG. 2 is a perspective view of an example of one embodiment of animplant device contemplated by this invention;

FIG. 3 is a top skeletal schematic view of bones in a typical human footillustrating a first metatarsal bone that has been cut or severedtransversely and a K-wire inserted into a first piece of the firstmetatarsal bone;

FIG. 4 is a top skeletal schematic representation of bones in a typicalhuman foot, illustrating an example of an implant device contemplated byembodiments of this invention, with the intramedullary portion insertedover the K-wire and into the first piece of the first metatarsal bonepiece and abutting or alongside the second metatarsal bone piece;

FIG. 5 is a top skeletal schematic representation of bones in a typicalhuman foot, illustrating an example of an implant device contemplated byembodiments of this invention, wherein a drill guide or template is usedto align the drilling of a transverse fastener aperture through thefastener aperture in the intramedullary portion of the implant, for thelater insertion of a screw there-through;

FIG. 6 is a top skeletal schematic representation of bones as shown inFIG. 4, and further illustrating bone fasteners secured within thesecond piece of the first metatarsal bone;

FIG. 7 is a box diagram flow chart of an example of a method or processcontemplated by embodiments of this invention;

FIG. 8 is a perspective view of another example of another embodiment ofan implant device contemplated by this invention;

FIG. 9 is a perspective view of another example of an embodiment of animplant device contemplated by this invention wherein the k-wireaperture is only through the intramedullary portion of the implantdevice;

FIG. 10 constitutes FIGS. 10A and 10B, which are different views ofanother embodiment of an implant device contemplated by embodiments ofthis invention;

FIG. 10A is top view and FIG. 10B is an elevation view of an example ofanother embodiment of an implant device contemplated by this invention;

FIG. 11 is a top view of an example of an embodiment of this inventionwherein the intramedullary portion of the implant device is at an anglerelative to the extramedullary portion;

FIG. 12 is an elevation view of an example of another embodiment of animplant device contemplated by this invention, wherein theintramedullary portion of the implant device is at an angle relative tothe extramedullary portion of the implant, only in a different planethan that illustrated in FIG. 11;

FIG. 13 is top skeletal schematic representation of bones in a typicalhuman foot, illustrating an example of an angled implant device (such asshown in FIG. 12) contemplated by embodiments of this invention, whereina drill guide or template is used to align the drilling of a transversefastener aperture through the fastener aperture in the intramedullaryportion of the implant, for the later insertion of a screwthere-through;

FIG. 14 is a perspective view of another example of an implant devicecontemplated by some embodiments of this invention;

FIG. 15 is a top view of the example of the implant device illustratedin FIG. 14;

FIG. 16 is a front view of the example of the implant device illustratedin FIG. 14;

FIG. 17 is an end view of the example of the implant device illustratedin FIG. 14;

FIG. 18 is a bottom view of the example of the implant deviceillustrated in FIG. 14;

FIG. 19 is section view 19-19 from FIG. 18;

FIG. 20 is a top partial view of the implant device illustrated in FIG.14;

FIG. 21 is a section view 21-21 from FIG. 20;

FIG. 22 is a box diagram flowchart of an example of a methodcontemplated by embodiments of this invention;

FIG. 23 is a top view of an example of the implanting of the implantdevice illustrated in FIG. 14, showing among other things, an alignmenttool;

FIG. 24 is the referenced detail view from FIG. 23; and

FIG. 25 is an alternative detail view from FIG. 23, which is anotheraspect or embodiment of that shown.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Many of the fastening, connection, manufacturing and other means andcomponents utilized in this invention are widely known and used in thefield of the invention described, and their exact nature or type is notnecessary for an understanding and use of the invention by a personskilled in the art or science; therefore, they will not be discussed insignificant detail. Furthermore, the various components shown ordescribed herein for any specific application of this invention can bevaried or altered as anticipated by this invention and the practice of aspecific application or embodiment of any element may already be widelyknown or used in the art or by persons skilled in the art or science;therefore, each will not be discussed in significant detail.

The terms “a”, “an”, and “the” as used in the claims herein are used inconformance with long-standing claim drafting practice and not in alimiting way. Unless specifically set forth herein, the terms “a”, “an”,and “the” are not limited to one of such elements, but instead mean “atleast one”.

Although the embodiments of this invention as applied to certain footsurgeries is primarily discussed to describe the invention, it will benoted by those of ordinary skill in the industry that the methods andapparatuses disclosed in this invention may be utilized in other bonerelated applications. For example, while the application discussed is ametatarsal osteotomy, it may be applied to osteotomies on other bones orpieces/parts of bones as well. Aspects of this invention may also beused to stabilize or fix two different bones together, including twobones comprising a joint. Still further embodiments of this inventionmay be utilized in fixing, stabilizing and/or aligning twoportions/parts/pieces of bones, all within the contemplation ofembodiments of this invention.

FIG. 1 is a top view of bones in a typical human foot 81 illustratingbunion and metatarsal issues. FIG. 1 shows first metatarsal bone 82,second metatarsal bone 83, third metatarsal bone 84, fourth metatarsalbone 85 and fifth metatarsal bone 86 of foot 81. FIG. 1 also shows thepair of first phalange bones 87 and second pair of phalange bones 88 forthe second or middle toe.

FIG. 1 illustrates the approximate center line 90 of the firstmetatarsal bone 82 as item 90, the approximate center line 92 for thephalange bones 87 for the first toe and the approximate center line 91for the second metatarsal bone 83. Angle 93 would represent the firstintermetatarsal angle (“IMA”) and angle 94 would represent an amountthat the phalanges rotated relative to the first metatarsal bone 82,while arrow 95 may be indicative of further rotation of that portion ofthe big toe.

FIG. 2 is a perspective view of an example of one embodiment of animplant device 101 contemplated by this invention, illustrating theframework with the intramedullary portion 102, extramedullary portion103, and the K-wire aperture 106 through both the intramedullary portion102 and the extramedullary portion 103.

FIG. 2 further illustrates fastener apertures 104, and an abutmentsurface 103 a which, in some embodiments of this invention, may beconfigured for abutment with a portion of the second piece of themetatarsal bone to which it is intended to be fastened. Theintramedullary portion 102 also includes transverse aperture 105.

In some embodiments of this invention, the intramedullary portion of theapparatus may be partially or fully inserted into the center or medullaportion of the bone, first bone or first section or piece of the bone.

In this application the term plate as used is not limited to anyparticular geometric shape such as a flat bodied portion, but instead isbroader than that and may include different and other shapes andconfigurations.

FIG. 3 is a top skeletal schematic view of bones in a typical human foot81 illustrating a first metatarsal bone 82 (shown in FIG. 1) having beentransversely cut and a K-wire 121 inserted into a first piece 82 b ofthe first metatarsal bone. FIG. 3 also illustrates first intermetatarsalangle 126 between the approximate center line of the first metatarsalbone and the approximate centerline 127 of the second metatarsal bone83.

FIG. 3 shows a second piece 82 a of the first metatarsal bone 82 (shownin FIG. 1) which has been cut, sawed or severed from first piece 82 b ofthe first metatarsal bone as part of the surgical procedure. The secondpiece 82 a of the metatarsal bone also includes surface 82 c, which mayhave been prepared or reformed by cutting, sawing and/or grinding toprovide an interface surface for the implant device (shown in otherfigures) to abut, fasten to and otherwise interact with.

Once the first metatarsal bone 82 (shown in FIG. 1) has been cut orsawed into a first bone piece 82 b and a second bone piece 82 a of thefirst metatarsal bone, and the desired surface area 82 c has been cutinto the second piece 82 a of the first metatarsal bone, the secondpiece 82 a of the first metatarsal bone 82 may be moved toward thesecond metatarsal bone 83 as illustrated by arrow 123.

The second piece 82 a of the first metatarsal bone 82 shown in FIG. 3would be relocated (represented by arrow 123) to a location which wouldproduce the desired or preferred alignment of the big toe or Halux. Oncethe second piece 82 a of the first metatarsal bone 82 is placed at thedesired angular and alignment location, the K-wire 121 may be implanted,inserted or forced (arrows 125) into the first piece 82 b of the firstmetatarsal bone 82 at a desired angle to enable the implant device (item99, FIG. 4) to be inserted over the K-wire 121 and provide the desiredangle for the big toe or Hallux.

FIG. 3 further illustrates a new center line 129 for the big toe, whichis angle 130 from the prior center line 128 of the first metatarsal bone82, and now only angle 131 offset from the centerline 127 of the secondmetatarsal bone 83.

In the embodiments which make use of a K-wire, this may eliminate theneed to drill a hole through the bone but instead the K-wire can be moreefficiently inserted through other known means with less or minimalnegative effects to the bone of the patient. It will be appreciated bythose of ordinary skill in the art that while a K-wire is referred toherein, this invention is not so limited as it includes a pin, wire,thin rod or other similar alignment component.

It will further be appreciated that the insertion of the K-wire into,for example, the first metatarsal piece may be accomplished in any oneof a number of different ways known in the art, such as forcedinsertion, screwing or through the use of tools, all within thecontemplation of this invention and with no one in particular beingrequired to practice this invention.

In the prior art situations in which a K-wire is used for temporaryalignment of the two pieces of bone, the wire must be removed before afixation device may be removed. The removal of the K-wire makes it muchmore difficult to consistently get as precise of an alignment as desiredfor the resulting fixed bone sections. In embodiments of this inventionand because of the wire aperture or cannulated feature of thisinvention, the K-wire or wire aperture can be slid over the K-wire toposition, align and guide the implant device to its desired and alignedlocation. During the alignment process the surgical area (and thealignment and position) of the K-wire can be readily seen through use ofx-ray device to further assist in more precisely obtaining the desiredangles.

FIG. 4 is a top skeletal schematic representation of bones in a typicalhuman foot 81, illustrating an example of an implant device 99contemplated by some embodiments of this invention, with theintramedullary portion 102 inserted over the K-wire 121 and into thefirst piece 82 b of the first metatarsal bone, and the extramedullaryportion 103 of the implant device 99 abutting or alongside the preparedsurface (shown as item 82 c in FIG. 3) in the second piece 82 a of thefirst metatarsal bone 82. FIG. 4 further shows a transverse screwaperture 99 for the transverse insertion of a screw through the bone andthe intramedullary portion 102.

FIG. 4 shows how the K-wire 121 serves as an initial alignment aid andthen as the guide inserting or implanting the intramedullary portion 102at the desired angle. It will be appreciated by those of ordinary skillin the art, the benefits and advantages of utilizing the K-wire 121 forthe alignment or re-alignment. Current practice requires the surgeonunder more difficult circumstances to more roughly estimate thealignment when inserting plates and other devices that are currentlyused as part of these types of surgeries.

FIG. 5 is a top skeletal schematic representation of bones in a typicalhuman foot, illustrating an example of an implant device 99 contemplatedby embodiments of this invention, wherein a drill guide or template 111is used to align the transverse drilling of a pilot hole through thebone and through a transverse screw aperture 113 in the intramedullaryportion of the implant device 99, for the later insertion of a screw (asshown in FIG. 6). The drill guide 111 is a template to providesufficient guidance and alignment of the drill 112 through drill hole115 in the drill guide such that the hole drilled through the bonealigns with the transverse screw or fastener aperture 113 in theintramedullary portion of the implant device. While the alignmentexample shown in FIG. 5 illustrates the use of two screws 114 which fixthe drill guide 111 relative to the implant device 99, other alignmentmechanisms or tools may be utilized within the contemplation ofembodiments of this invention, with no one being required to practicethis invention.

FIG. 6 is a top skeletal schematic representation of the foot 81 asshown in FIG. 4, and further illustrates bone fasteners 128 (screws inthe example of the embodiment shown) that have been placed through thefastener apertures 104 (shown in FIG. 4) in the extra-medullary portion103 of the implant device 99 and secured or fastened within the secondpiece 82 a of the first metatarsal bone. Bone fastener 116, a screw inthis example, is shown transversely screwed into the bone through thescrew aperture in the intramedullary portion 102 of the implant device99. FIG. 6 also shows phalange bones 87 of the big toe, as well as thenew angle 131 between the new centerline 129 of the big toe and thecenterline 127 of the second toe.

It will be noted and appreciated by those of ordinary skill in the artthat this invention is not limited to any one particular bone fastener,but instead any one of a number of known and to be discovered bonefasteners may be utilized within the contemplation of this invention,such as without limitation, bone screws, bone nails and the like.

FIG. 7 is a box diagram flow chart of an example of a method or processcontemplated by embodiments of this invention. The first step in FIG. 7is the beginning of a surgery in which the patient's tissue must beparted in order to expose the first metatarsal bone of the patient'sfoot to provide sufficient vision and clearance for the remaining stepsof the surgical alignment and stabilization process, as well as theinstallation of the implant device.

The next step involves the transverse cutting, sawing or severing of thefirst metatarsal bone of the patient into at least a first piece and asecond piece. Then the second piece of the first metatarsal bone isplaced into the desired alignment with the first piece of the firstmetatarsal bone for the desired angular result, as shown in FIG. 3.

There is an intermediate elective next step that may be and ispreferably performed, and that is preparing a surface on the secondpiece of the first metatarsal bone to better receive and interact withthe extramedullary portion of the implant device. It is preferred tocreate a flat surface on the second piece of the first metatarsal boneto provide a surface or interface to which the extramedullary portion ofthe implant device can be fastened. The surface may be prepared bygrinding or cutting tools or in other ways customary in the trade.

The first end of a wire may then be inserted or implanted within thefirst piece of the first metatarsal bone, aligning the second end of thewire substantially alongside the second piece of the first metatarsalbone surface to which the extramedullary portion of the implant devicewill be fastened or attached. It is without limitation at thisapproximate stage that the benefits of utilizing a wire for alignmentcombined with a cannulated implant device can be achieved. The wire maybe utilized through x-rays or visual observation to obtain the desiredalignment of not only the first and second pieces of the firstmetatarsal bone, but also the general alignment of the toe in questionwhich would also include the phalange bones.

Once the first piece and the second piece of the first metatarsal boneare aligned and the wire is inserted into the first piece with thedesired alignment, an embodiment of an implant device may be provided.

An implant device is provided which may include an elongated frameworkwhich includes the intramedullary portion and the extramedullaryportion, the extramedullary portion including at least one fasteneraperture disposed to receive one or more bone fasteners to affix theextramedullary portion of the implant device to the second piece of thefirst metatarsal bone. Embodiments of the implant device are cannulatedin that those embodiments have a contiguous wire aperture through boththe intramedullary portion and the extramedullary portion of itsframework. This allows the implant device to receive the wire in thewire aperture and slide down the second end of the wire with theintramedullary portion first. However, in other embodiments the wireaperture may provide interaction with the wire through a non-contiguousand/or intermittent wire aperture that extends partially or whollythroughout the length of the intramedullary portion.

Once the intramedullary portion reaches the location on the first pieceof the first metatarsal bone where the wire protrudes, it can be forcedor implanted into the first metatarsal bone with the already implantedportion of the wire serving as its directional guide and therebyaligning the implant device.

Once the intramedullary portion of the implant device is inserted orimplanted into the first piece of the first metatarsal bone to thedesired depth, the extramedullary portion of the implant device shouldbe positioned alongside and/or abutting the desired surface of thesecond piece of the first metatarsal bone (with the second end of thewire protruding through the top of the wire aperture in theextramedullary portion of the implant device).

Fasteners may be placed through the fastener apertures in theextramedullary portion transversely to fasten the extramedullary portionto the second piece of the first metatarsal bone. It will be appreciatedby those of ordinary skill in the art that any one of a number ofdifferent types of fasteners may be utilized to attach, fasten or securethe extramedullary portion of the implant device to the second piece ofthe first metatarsal bone, with no one particular being required topractice this invention. A preferred fastening mechanism is the use ofbone screws or bone nails.

Once the proper alignment of the implant device has been achieved, thewire may be removed, although it does not have to be removed to practicethis invention.

FIG. 8 is a perspective view of another example of another embodiment ofan implant device 180 contemplated by this invention. FIG. 8 illustratesimplant device 180, intramedullary portion 181 of the implant deviceframework, as well as the extramedullary portion 183 of the implantdevice framework or body. The intramedullary portion 181 includes a wireor wire aperture 182 there-through configured to receive and combinewith wire 185 to provide alignment for the implant device via the wire185.

Bone fastener apertures 187 through extramedullary portion 183 providethe aperture through which fasteners may be inserted transversely tothen fasten the extramedullary portion 183 to a bone or piece of bone.FIG. 8 also illustrates that the wire aperture need not be fully closed,but must provide an appropriate aperture clearance or tolerance so thatthe wire 185 can combine with the wire aperture in the implant device toprecisely align the implant device and assist in the alignment of thebones or pieces of bones that are being aligned or realigned as they arebeing fixed or stabilized by the implant device. FIG. 8 shows threeguides 186 or bridges on the surface 183 a of the extramedullary portion183 and through which the wire 185 (which may also be referred to as apin or K-wire) is inserted.

While FIG. 8 shows the intramedullary portion 181 without any transversescrew apertures, it should be noted that this embodiment may also beprovided with transverse screw or other fastening apertures as shown inother figures, with this invention not being limited to any one suchconfiguration.

FIG. 9 is a perspective view of another example of an embodiment of animplant device 180 contemplated by this invention wherein the k-wireaperture 182 only extends through the intramedullary portion 181 of theimplant device 180 and does not also extend through the extramedullaryportion 183 as shown in other figures herein. The k-wire 185 in thisexample of an embodiment instead abuts or is adjacent to the surface 183a of the extramedullary portion 183.

FIG. 9 illustrates transverse apertures 190 (for fasteners or screws)through the intramedullary portion 181. The transverse apertures 190 maybe normal or perpendicular to the axis of the intramedullary portion (orto the k-wire), or one or more of the transverse apertures may also beat an angle to facilitate for example the angles between theextramedullary portion and intramedullary portion illustrated in FIG.11, FIG. 12 or FIG. 13, as examples. FIG. 9 also shows fastenerapertures 187 in the extramedullary portion 183.

It should also be noted that there may be multiple transverse aperturesin the intramedullary portion 181 of the implant device 180, with afirst transverse aperture being at a dissimilar angle to a secondtransverse aperture, to achieve desired results according to theparticular application of the invention.

FIG. 10 constitutes FIGS. 10A and 10B, which are different views ofanother embodiment of an implant device 200 contemplated by embodimentsof this invention as described below relative to the description ofFIGS. 10A and 10B.

FIG. 10A is a top view and FIG. 10B is an elevation view of an exampleof another embodiment of an implant device 200 contemplated by thisinvention, illustrating extramedullary portion 202 with transverseapertures 203 (which may be used as fastener apertures as shown in FIG.6, and/or as a means to attach a drill guide or template as shown inFIGS. 5 & 13, all within the contemplation of this invention),intramedullary portion 201 with a plurality of transverse fastenerapertures 204.

FIG. 11 is a top view of an example of an embodiment of an implantdevice 210 contemplated by this invention, wherein the intramedullaryportion 211 of the implant device 210 is at an angle 219 relative to theextramedullary portion 212. FIG. 11 shows extramedullary portion 212with transverse apertures 213 (which may be used as fastener aperturesas shown in FIG. 6, and/or as a means to attach a drill guide ortemplate as shown in FIGS. 5 & 13, all within the contemplation of thisinvention), intramedullary portion 211 with a plurality of transversefastener apertures 214. The angle 219 in this embodiment is the anglebetween the centerline or axis 218 of the intramedullary portion 211 andthe angle of the centerline of the fastener apertures 213 and/or of theextramedullary portion 212. It may be desirable for some patientconditions to impart an angle such as angle 219 between the differentparts of the metatarsal bone.

FIG. 12 is an elevation view of an example of another embodiment of animplant device 250 contemplated by this invention, wherein theintramedullary portion 251 of the implant device 250 is at an angle 255relative to the extramedullary portion 252 of the implant 250, but theangle is in a different plane than the angle in FIG. 11. FIG. 12illustrates extramedullary portion 252 with transverse apertures 257(which may be used as fastener apertures as shown in FIG. 6, and/or as ameans to attach a drill guide or template as shown in FIGS. 5 & 13, allwithin the contemplation of this invention), intramedullary portion 251with a plurality of transverse fastener apertures 256. The angle 255 inthis embodiment is the angle between the centerline or axis 254 of theintramedullary portion 251 and the downward angle of the centerline ofthe extramedullary portion 252. It may be desirable for some patientconditions to impart an angle, such as angle 255, between the differentparts of the metatarsal bone (as shown in FIG. 13).

It should be noted that the particular angle desired may vary frompatient to patient, and may be determined in advance of surgery, oraltered during the course of the surgery to adapt to the angle of thebones and cuts made in or on the bones, all within the contemplation ofembodiments of this invention. Known bending methods and devices may beutilized to bend or alter the angle such as shown as angle 255 in FIGS.12 & 13.

FIG. 13 is top skeletal schematic representation of bones in a typicalhuman foot, illustrating an example of an embodiment of an implantdevice 250 (one example of which is shown in FIG. 12) contemplated byembodiments of this invention, wherein a drill guide 227 or template isused to align the drilling of a hole to facilitate the insertion of afastener 229 (a screw in this example) through the bone 220 and throughthe transverse fastener aperture in the intramedullary portion 251 ofthe implant device 250. This process may be practiced in a similarmanner to that process described above regarding FIG. 5.

The drill guide 227 is a template to provide sufficient guidance andalignment of the drill 228 through the bone and through a fasteneraperture in the screw (examples of which are shown in FIG. 12) such thatthe hole drilled through the bone aligns with the screw aperture in theintramedullary portion of the implant device. FIG. 13 shows the angle255 between a centerline 224 of the intramedullary portion 251 and acenterline 225 of the extramedullary portion 252. Drill alignment guide227 is shown fixed to the extramedullary portion 252 via screws 230, tosecure the drill guide 227 in place to facilitate the drilling of a holethrough the bone that aligns with the transverse fastener aperture(shown in other figures) in the intramedullary portion 251 of theimplant 250. In this case the screws will be inserted at an angle to theintramedullary portion. The drill configuration is shown forillustration purposes only as there would not be drilling after thescrew 229 is inserted, and is further not to scale—but instead the pilothole for the screw would be drilled to the sizing, depth andconfiguration desired.

It will be noted and appreciated by those of ordinary skill in the artthat the K-wire aperture or wire aperture may, but need not, be a fullyenclosed uninterrupted aperture through both the intramedullary portionand the extramedullary portion of the implant device framework. The wireaperture or cannulated feature may also be dis-continuous in that theremay be interruptions or breaks in the aperture so along as the wire isconsistently located and surrounded to allow the wire to be used as analignment device or mechanism for the implant device. The wire aperturetherefore may be a less than complete slit through which the wire may beinserted and retained for the alignment purposes stated herein.

It should be noted that while the drawings and general description aredirected toward the metatarsal bone in a foot, the implant device andmethod described herein may equally be used in other applications, withno one particular application being required to practice this invention.

FIG. 14 is a perspective view of another example of an implant device300 contemplated by some embodiments of this invention, transversefastener apertures 303 & 306, intramedullary portion 301, extramedullaryportion 302, wire apertures 307, extramedullary fastener apertures 304 &305.

FIG. 15 is a top view of the example of the implant device 300illustrated in FIG. 14, illustrating intramedullary portion 301 andextramedullary portion 302. Like numbered items referenced in priorfigures may not be repeated herein.

FIG. 16 is a front view of the example of the implant device 300illustrated in FIG. 14, showing transverse fastener apertures 303 in theintramedullary portion 301 and transverse fastener aperture 304 in theextramedullary portion, the extramedullary portion 302 being at angle310 relative to the axis of intramedullary portion 301. Like numbereditems referenced in prior figures may not be repeated herein.

FIG. 17 is an end view of the example of the implant device 300illustrated in FIG. 14, showing wire aperture 307 and extramedullaryportion 302. A guide wire or K-wire may be utilized to position and orangle where the extramedullary portion is inserted into the metatarsalbone, and then the intramedullary portion may be inserted into the boneover the guide wire, and thereby positioned as guided by wire aperture307. Like numbered items referenced in prior figures may not be repeatedherein.

FIG. 18 is a bottom view of the example of the implant device 300 shownin FIG. 14, illustrating intramedullary portion 301, wire guide 307,extramedullary portion 302 and transverse fastener aperture 304 in theextramedullary portion 302. Like numbered items referenced in priorfigures may not be repeated herein.

FIG. 19 is section view 19-19 from FIG. 18, illustrating the implantdevice 300 with wire guide aperture 307 and intramedullary portion 301.

FIG. 20 is a top partial view of the implant device 300 illustrated inFIG. 14, showing intramedullary portion 301, wire guide aperture 307,transverse fastener aperture 306, extramedullary portion 302, transversefastener apertures 304 and 305 with extramedullary portion 302.

FIG. 21 is a section view 21-21 from FIG. 20, illustrates implant device300, extramedullary portion 302, intramedullary portion 301 and wireguide aperture 307.

FIG. 22 is a box diagram flowchart of an example of an embodiment of amethod contemplated by this invention. In the first step illustrated inFIG. 22, the deformity is assessed and the translation calculated,determining if and how much rotational correction may be needed for thedeformity in question. Though this invention is not limited to it, acurrent tool in determining the translation and rotational correction isa sesamoidal axial image.

At that time an incision may be made to expose the bone which is to beoperated on, and the medial bone is altered or a portion removed tocreate a surface (which may but need not be a flat surface) to prepareit for the fixation or attachment of the implant device. In embodimentsof this invention, this would involve making a flat surface for theattachment of the plate portion of the implant device (theextramedullary portion).

A further step would be to then create an osteotomy in the firstmetatarsal behind the sesamoids, followed by the translation of themetatarsal head laterally and the rotation of the metatarsal head to thedesired position in all planes.

Once the metatarsal head is in the desired position, the guide wire maybe placed into the metatarsal shaft to hold the metatarsal head intoproper position. Once the guide wire is placed and located as desired,the plate portion (extramedullary portion) may be placed over theguidewire into the metatarsal shaft.

At that stage the plate portion may be fixated to the metatarsal headwith any one of a number of different fasteners, such as one or twoscrew(s).

The drill guide is preferably then attached over the guide wire andfastened/attached to the plate portion of the implant device.

Once the drill guide and other components are in place, an alignmentcheck of the metatarsal head can be made and adjustments may be made forexample by applying compression to move it to a more desired position,and/or a rotational force may be applied to rotationally adjust theposition of the metatarsal head. During this process, known imagingequipment may be utilized to provide and use a sesamoidal axial image toconfirm proper alignment.

An alignment tool may be utilized in embodiments of this invention tofacilitate the compression and rotational adjustments. As described morefully below, the tool may be unitary or separate from the drill guide(preferably integral therewith), and would be attachable and detachableto the implant device already inserted in the metatarsal shaft to act asa targeting adjusting tool.

Once the final micro-adjustments have been made, the proximal screwholes may be drilled as desired and the proximal screws may be placed orinserted.

The instruments may then be removed, final alignment positioningconfirmed and the incisions may then be closed.

FIG. 23 is a top view of an example of the implanting of the implantdevice 300 illustrated in FIG. 14, showing among other things, analignment tool comprised of handle 322, transverse or proximal screwguide portion 324 and implant device attachment portion 325. FIG. 23shows the extramedullary portion of the implant device 300 fastenedmetatarsal head 321 via cannulated screws 332 with an exemplary guidewires 330 (for the extramedullary portion) and exemplary guide wires 328& 329 for the intramedullary portion. FIG. 23 further shows how theproximal screw guide portion 324 is utilized with alignment guide wires328 and 329, with cannulated screws 326 and 327 being placed or fastenedinto bone 320 once the proper positioning alignment has been achieved,as set forth and described elsewhere herein. Arrow 335 illustrates howthe alignment tool may be rotated to place the implant device in thedesired rotationally aligned position and arrow 336 illustrates how thealignment tool may be moved laterally or on a plane to place the implantdevice in the desired position.

FIG. 24 is detail view from FIG. 23, and illustrates an example of oneembodiment that may be utilized to practice this invention. FIG. 24shows handle 322 with a shaft 333 extending there through, the shaft 333being externally threaded at 333 a and operably attached to a rotatableend 322 a of handle 322. The surgeon can then rotate the rotatable end322 a to thereby cause the external threads 333 a to engage ininternally threaded aperture 300 a in the implant device.

The configuration illustrated in FIG. 24 allows the surgeon to fix thehandle to the implant device before the proximal screws are fixed andthereby manipulate the location and rotational angle of the implantdevice to the most desired location, as described more fully above.Although a threaded attachment and detachment mechanism or means isillustrated, it will be appreciated by those of ordinary skill in theart that any one of a number of attachable and detachable fasteningmechanisms and means may be utilized, all within the contemplation ofthis invention, with no one being required to practice this invention.Aspects or embodiments of an implant alignment tool as shown in FIG. 24may include an externally threaded shaft 333 configured to fasten to andunfasten from to an internally threaded aperture 300 a in the implantdevice. One way to practice this embodiment of the invention is tofurther rotatably mount the shaft 333 relative to the handle 322 of theimplant alignment tool such that it can be rotated (as shown by thearrow) to fasten it to the implant device and rotated an oppositedirection to unfasten it from the implant device.

FIG. 25 is an alternative detail view from FIG. 23, which is an exampleof another way to practice an embodiment of this invention wherein thealignment tool is attachable and detachable to the implant device 300.In FIG. 25, the alignment tool aperture 335 in the implant device 300receives attachment protrusion 334 which is part of the alignment tool,and the aperture 335 in the implant device is sized and/or shaped (suchas by a truncated configuration—but not limited thereto) so that a solidfixed connection may occur to manipulate the implant device 300, beforedetaching it. In one aspect or example of this embodiment, a shaft 334is sized relative to a shaft aperture 335 in the implant device suchthat the implant alignment tool may be fastened to and unfastened fromthe implant device via a friction fit.

As will be appreciated by those of reasonable skill in the art, thereare numerous embodiments to this invention, and variations of elementsand components which may be used, all within the scope of thisinvention. In one embodiment for example, an implant device configuredfor implanting in a patient to align or stabilize a first bone sectionrelative to a second bone section of a patient, the implant comprising:an elongated framework including an intramedullary portion integral withan extramedullary portion, configured to attach a first bone section toa second bone section; the intramedullary portion configured forinsertion into the first bone section and including at least onefastener aperture configured to transversely receive a bone fastenerthere-through; the extramedullary portion configured to abut a surfaceof the second bone section and including at least one fastener aperturedisposed to transversely receive a bone fastener inserted in the secondbone section; a wire aperture through the intramedullary portion of theframework, disposed to receive and be guided by a wire inserted in thefirst bone section as the intramedullary portion is inserted into thefirst bone.

In addition to the embodiment disclosed in the preceding paragraph,further embodiments may be: further wherein the contiguous wire apertureis a slit in the framework; further wherein the contiguous wire apertureis a fully enclosed guide or cannula in the framework; further whereinthe contiguous wire aperture is a continuous fully enclosed aperture inthe framework; further wherein the intramedullary portion is generallycircular or oval and the extramedullary portion is a plate; furtherwherein the at least one fastener aperture is comprised of a firstfastener aperture and a second fastener aperture spaced apart on theextramedullary portion of the framework (further wherein the first andsecond fastener apertures are configured to combine with a first bonefastener inserted through the first fastener aperture and a second bonefastener inserted through the second fastener aperture, to secure theextramedullary portion of the framework to the first bone of thepatient); further wherein the first bone of the patient is a first pieceof the first metatarsal bone and the second bone of the patient is asecond piece of the first metatarsal bone; further wherein theextramedullary portion includes a wire aperture also disposed to receiveand be guided by the wire inserted in the first bone section as theintramedullary portion is inserted into the first bone section, the wireaperture in the extramedullary portion being contiguous with the wireaperture in the intramedullary portion; further wherein theextramedullary portion is bent at an angle relative to theintramedullary portion such that it is disposed to affix to a surface ofthe second bone section; further wherein the extramedullary portion isbent at a transverse angle relative to the intramedullary portion suchthat it is disposed to affix to a surface of the second bone section;and/or further wherein the wire is a k-wire.

In another embodiment, a method embodiment, a method to re-align andstabilize a patient's metatarsal bone may be provided which comprises:transversely severing the first metatarsal bone at a desired location,resulting in a first piece and a second piece of the first metatarsalbone; placing the second piece of the first metatarsal bone in thedesired alignment with the first piece; inserting a first end of a wireinto the first piece of the first metatarsal bone at a desired angle andsuch that a second end of the wire is substantially aligned alongsidethe second piece; providing an implant device comprised of: an elongatedframework including an intramedullary portion and an extramedullaryportion, the extramedullary portion including at least one fasteneraperture disposed to transversely receive a bone fastener to affix theextramedullary portion to the second piece of the first metatarsal bone;and a contiguous wire aperture axially through the intramedullaryportion; sliding the wire aperture of the intramedullary portion overthe second end of the wire and sliding the implant device over the wireuntil the intramedullary portion of the implant device is implanted intothe first piece of the metatarsal bone; and fastening the extramedullaryportion of the implant device to the second piece of the firstmetatarsal bone by inserting a fastener through the at least onefastener aperture and into the second piece of the first metatarsalbone; and fastening the intramedullary portion of the implant device tothe first piece of the first metatarsal bone by inserting a fastenerthrough the at least one fastener aperture and into the first piece ofthe first metatarsal bone.

In addition to the embodiment disclosed in the preceding paragraph,further embodiments may be: further comprising the step of reforming thefirst piece of the metatarsal bone to provide a surface which disposesit to better attach to the extramedullary portion of the implant device;further wherein the reforming of the first piece of the metatarsal boneincludes cutting a substantially planar surface disposed for abutment tothe extramedullary portion of the implant device; further comprisingbending the extramedullary portion relative to the intramedullaryportion such that the extramedullary portion more desirably abutssubstantially planar surface on the second piece of the patient'smetatarsal bone; further comprising the step of using the wire alignmentangle to align the insertion of the intramedullary portion into thefirst piece of the metatarsal bone; further comprising the step of usingthe wire alignment angle to align the position of the extramedullaryportion of the implant device relative to the mounting location on thesecond piece of the metatarsal bone; further wherein the bone fasteneris a bone screw; further wherein the step of fastening theintramedullary portion of the implant device to the first piece of thefirst metatarsal bone by inserting a fastener through the at least onefastener aperture and into the first piece of the first metatarsal bone,is performed before the step of fastening the extramedullary portion ofthe implant device to the second piece of the first metatarsal bone byinserting a fastener through the at least one fastener aperture and intothe second piece of the first metatarsal bone; and/or further whereinthe step of fastening the intramedullary portion of the implant deviceto the first piece of the first metatarsal bone by inserting a fastenerthrough the at least one fastener aperture and into the first piece ofthe first metatarsal bone, further comprises: fixing a drill guide tothe extramedullary portion, the drill guide including a drill aperturewhich is thereby fixed and aligned relative to the transverse fasteneraperture in the intramedullary portion such that a pilot hole may bedrilled through a portion of the first bone piece and through thetransverse fastener aperture in the intramedullary portion, therebyfurthering the securement of the intramedullary portion to the firstbone piece.

In yet a more general method embodiment, a method to re-align andstabilize a patient's bone may be provided which comprises: transverselysevering the patient's bone at a desired location, resulting in a firstpiece and a second piece of the patient's bone; placing the second pieceof the patient's bone in the desired alignment with the first piece;inserting a first end of a wire into the first piece of the patient'sbone at a desired angle and such that a second end of the wire issubstantially aligned alongside the second piece; providing an implantdevice comprised of: an elongated framework including an intramedullaryportion and an extramedullary portion, the extramedullary portionincluding at least one fastener aperture disposed to transverselyreceive a bone fastener to affix the extramedullary portion to thesecond piece of the patient's bone; and a contiguous wire apertureaxially through the intramedullary portion; sliding the wire aperture ofthe intramedullary portion over the second end of the wire and slidingthe implant device over the wire until the intramedullary portion of theimplant device is implanted into the first piece of the patient's bone;and fastening the extramedullary portion of the implant device to thesecond piece of the patient's bone by inserting a fastener through theat least one fastener aperture and into the second piece of thepatient's bone; and fastening the intramedullary portion of the implantdevice to the first piece of the patient's bone by inserting a fastenerthrough the at least one fastener aperture and into the first piece ofthe patient's bone.

In another embodiment, an implant alignment tool may be provided for usein combination with an implant device, configured for aligning animplant device in a patient being implanted to stabilize a first bonesection relative to a second bone section of a patient, the implantalignment tool comprising: a handle; a proximal screw guide portionextending from said handle; and an implant device attachment portion.

Additional embodiments from those in the preceding paragraph may includesuch an implant alignment tool: wherein the implant device attachmentportion is further comprised of an externally threaded shaft configuredto fasten to and unfasten from to an internally threaded aperture in theimplant device, and optionally further wherein the shaft is rotatablymounted relative to the handle of the implant alignment tool such thatit can be rotated to fasten it to the implant device and rotated anopposite direction to unfasten it from the implant device.

An additional embodiment from that described in the second precedingparagraph may be further wherein the shaft is sized relative to a shaftaperture in the implant device such that the implant alignment tool maybe fastened to and unfastened from the implant device via a frictionfit.

Another method embodiment may include a method to re-align and stabilizea patient's metatarsal bone comprising: assessment of a deformity to beremedied, including the desired translational and rotational correction;make incision to expose the metatarsal bone; remove a medial bone tocreate an appropriate surface for receiving a portion of an implantdevice; create an osteotomy in a first metatarsal bone behind thesesamoids; translate the metatarsal head laterally and rotate head tothe desired position in all planes; place a guide wire into a shaft ofthe metatarsal bone to locate the metatarsal head into a desiredposition; providing an implant device comprised of: an elongatedframework including an intramedullary portion and an extramedullaryportion, the extramedullary portion including at least one fasteneraperture disposed to transversely receive a bone fastener to affix theextramedullary portion to the second piece of the first metatarsal bone;and a contiguous wire aperture axially through the intramedullaryportion; place the extramedullary portion over the guide wire and intothe shaft of the metatarsal; fixate the extramedullary portion to themetatarsal head with one or more fasteners; attach a drill guide overthe wire and fast the drill guide to the extramedullary portion;evaluate and adjust the alignment of the metatarsal head utilizing theimplant adjustment tool; drill proximal fastener apertures in themetatarsal bone; and place proximal fasteners into the metatarsal bone.

In compliance with the statute, the invention has been described inlanguage more or less specific as to structural and methodical features.It is to be understood, however, that the invention is not limited tothe specific features shown and described, since the means hereindisclosed comprise preferred forms of putting the invention into effect.The invention is, therefore, claimed in any of its forms ormodifications within the proper scope of the appended claimsappropriately interpreted in accordance with the doctrine ofequivalents.

I/We claim:
 1. An implant alignment tool for use in combination with animplant device, configured for aligning an implant device in a patientbeing implanted to stabilize a first bone section relative to a secondbone section of a patient, the implant alignment tool comprising: ahandle; a proximal screw guide portion extending from said handle; andan implant device attachment portion.
 2. An implant alignment tool asrecited in claim 1, and wherein the implant device attachment portion isfurther comprised of an externally threaded shaft configured to fastento and unfasten from to an internally threaded aperture in the implantdevice.
 3. An implant alignment tool as recited in claim 2, and furtherwherein the shaft is rotatably mounted relative to the handle of theimplant alignment tool such that it can be rotated to fasten it to theimplant device and rotated an opposite direction to unfasten it from theimplant device.
 4. An implant alignment tool as recited in claim 1, andfurther wherein the shaft is sized relative to a shaft aperture in theimplant device such that the implant alignment tool may be fastened toand unfastened from the implant device via a friction fit.
 5. A methodto re-align and stabilize a patient's metatarsal bone comprising:assessment of a deformity to be remedied, including the desiredtranslational and rotational correction make incision to expose themetatarsal bone; remove a medial bone to create an appropriate surfacefor receiving a portion of an implant device; create an osteotomy in afirst metatarsal bone behind the sesamoids; translate the metatarsalhead laterally and rotate head to the desired position in all planes;place a guide wire into a shaft of the metatarsal bone to locate themetatarsal head into a desired position; providing an implant devicecomprised of: an elongated framework including an intramedullary portionand an extramedullary portion, the extramedullary portion including atleast one fastener aperture disposed to transversely receive a bonefastener to affix the extramedullary portion to the second piece of thefirst metatarsal bone; and a contiguous wire aperture axially throughthe intramedullary portion; place the extramedullary portion over theguide wire and into the shaft of the metatarsal; fixate theextramedullary portion to the metatarsal head with one or morefasteners; attach a drill guide over the wire and fast the drill guideto the extramedullary portion; evaluate and adjust the alignment of themetatarsal head utilizing the implant adjustment tool; drill proximalfastener apertures in the metatarsal bone; and place proximal fastenersinto the metatarsal bone.
 6. A method to re-align and stabilize apatient's metatarsal bone as recited in claim 5, and further wherein theassessment of the deformity to be remedied is made utilizing asesamoidal axial image.
 7. A method to re-align and stabilize apatient's metatarsal bone as recited in claim 5, and further comprisingthe steps of confirming the desired alignment and then closing theincisions.
 8. A method to re-align and stabilize a patient's metatarsalbone as recited in claim 6, and further wherein the reforming of thefirst piece of the metatarsal bone includes cutting a substantiallyplanar surface disposed for abutment to the extramedullary portion ofthe implant device.
 9. A method to re-align and stabilize a patient'smetatarsal bone as recited in claim 7, and further comprising bendingthe extramedullary portion relative to the intramedullary portion suchthat the extramedullary portion more desirably abuts substantiallyplanar surface on the second piece of the patient's metatarsal bone. 10.A method to re-align and stabilize a patient's metatarsal bone asrecited in claim 5, and further comprising the step of using the wirealignment angle to align the insertion of the intramedullary portioninto the first piece of the metatarsal bone.
 11. A method to re-alignand stabilize a patient's metatarsal bone as recited in claim 5, andfurther comprising the step of using the wire alignment angle to alignthe position of the extramedullary portion of the implant devicerelative to the mounting location on the second piece of the metatarsalbone.
 12. A method to re-align and stabilize a patient's metatarsal boneas recited in claim 5, and further wherein the bone fastener is a bonescrew.
 13. A method to re-align and stabilize a patient's metatarsalbone as recited in claim 5, and further wherein the step of fasteningthe intramedullary portion of the implant device to the first piece ofthe first metatarsal bone by inserting a fastener through the at leastone fastener aperture and into the first piece of the first metatarsalbone, is performed before the step of fastening the extramedullaryportion of the implant device to the second piece of the firstmetatarsal bone by inserting a fastener through the at least onefastener aperture and into the second piece of the first metatarsalbone.
 14. A method to re-align and stabilize a patient's metatarsal boneas recited in claim 5, and further wherein the step of fastening theintramedullary portion of the implant device to the first piece of thefirst metatarsal bone by inserting a fastener through the at least onefastener aperture and into the first piece of the first metatarsal bone,further comprises: fixing a drill guide to the extramedullary portion,the drill guide including a drill aperture which is thereby fixed andaligned relative to the transverse fastener aperture in theintramedullary portion such that a pilot hole may be drilled through aportion of the first bone piece and through the transverse fasteneraperture in the intramedullary portion, thereby furthering thesecurement of the intramedullary portion to the first bone piece.